| Methods |
2‐arm active‐controlled double‐dummy randomised trial |
| Participants |
401 women were randomised in a hospital setting in Ghana. The population comprised women of parity 5 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing induction or augmentation of labour or caesarean section, or those with grand multiparity (more than 5), multiple pregnancy, preterm labour (less than 32 weeks), hypertension in pregnancy, HELLP syndrome, polyhydramnios, previous PPH, coagulopathy, precipitate labour, chorioamnionitis, Hb less than 80 g/L or a known hypersensitivity to prostaglandins. |
| Interventions |
400 mcg of misoprostol administered orally versus 10 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; death; blood loss (mL); change in Hb; third stage duration (minutes); diarrhoea; nausea; vomiting; fever; shivering. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random numbers. |
| Allocation concealment (selection bias) |
Low risk |
Used sequentially‐numbered, opaque packets made by administrative staff. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The identity of the placebo and active medications were concealed from caregivers and participants". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
High risk |
Investigators appraised blood loss by the estimation of attending physicians. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Of those women randomised, blood loss measurements were unavailable in 3 cases, and postpartum Hb samples were unavailable in 9 cases. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
Low risk |
All those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised. |
| Funding source |
Low risk |
The study was supported by funding from MaterCare International and the Canadian International Development Agency (public funding). |
